Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000832279p
Ethics application status
Submitted, not yet approved
Date submitted
16/04/2018
Date registered
16/05/2018
Date last updated
16/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
How Does Spinal Anesthesia Effect Eye Pressure During Surgery
Scientific title
The Effect of Spinal Anesthesia on Intraoculary Pressure During Lower Extremity Surgery
Secondary ID [1] 294478 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower extremity surgery
 307240 0
spinal anesthesia 307241 0
Condition category
Condition code
Anaesthesiology 306359 306359 0 0
Other anaesthesiology
Eye 306546 306546 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
intraocular pressure will be measured with applanation tonometer. All cases will be evaluated before surgery(first intraoculary pressure measurement), then the second measurement will be done 5 minutes after spinal anesthesia was applied.
Intervention code [1] 300772 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305368 0
intraocular pressure changes will be observed with tonometer.
Timepoint [1] 305368 0
10 minutes before spinal anesthesia and 10 minutes after surgery got started.
Secondary outcome [1] 344968 0
nil
Timepoint [1] 344968 0
nil

Eligibility
Key inclusion criteria
voluntary patients
ASA physical status I-II patients
Aged 18-65 years
Elective artroscopic knee surgery
patients who are operated under spinal anesthesia
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic diseases except regular hypertension
Known allergies to any anesthetic drugs used in the study
Eye disease or surgery in the medical history
Any contrendications for spinal anesthesia

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Student T test will be used for the normal ranged data
Mann Whitney U test will be used for data that was except of the normal range.
Categorical data will be compared with Chi-square test. p<0.05 is accepted as significant.Data was analyzed using SPSS 16 software.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 10247 0
Turkey
State/province [1] 10247 0
konya

Funding & Sponsors
Funding source category [1] 299242 0
Hospital
Name [1] 299242 0
Konya Training and Research Hospital
Country [1] 299242 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Haci Saban Mah Meram yeniyol caddesi, Meram/ Konya / Turkey
Country
Turkey
Secondary sponsor category [1] 298358 0
None
Name [1] 298358 0
Address [1] 298358 0
Country [1] 298358 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300036 0
ethical committe of necmettin erbakan university hospital
Ethics committee address [1] 300036 0
Yunus Emre Mh., Necmettin Erbakan Üniversitesi, 42080 Meram/Konya TURKEY
Ethics committee country [1] 300036 0
Turkey
Date submitted for ethics approval [1] 300036 0
16/04/2018
Approval date [1] 300036 0
Ethics approval number [1] 300036 0

Summary
Brief summary
Intraocular pressure (IOP) depends on the balance between humoral fluid production and drainage, and different pressures can be measured between the right and left eyes with stimuli causing sympathoadrenal stimulation such as laryngoscopy and endotracheal intubation (about 5 min).

It has been aimed to investigate how does spinal anesthesia change the intraoculary pressure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82342 0
Dr eyup aydogan
Address 82342 0
Konya Training and Research Hospital, Anesthesiology Department, Hacisaban Mahallesi, Yeni Meram Cd. No:97, 42090 Meram/Konya
Country 82342 0
Turkey
Phone 82342 0
+90 332 221 0000
Fax 82342 0
Email 82342 0
[email protected]
Contact person for public queries
Name 82343 0
eyup aydogan
Address 82343 0
Konya Training and Research Hospital, Anesthesiology Department, Hacisaban Mahallesi, Yeni Meram Cd. No:97, 42090 Meram/Konya
Country 82343 0
Turkey
Phone 82343 0
+90 332 221 0000
Fax 82343 0
Email 82343 0
[email protected]
Contact person for scientific queries
Name 82344 0
eyup aydogan
Address 82344 0
Konya Training and Research Hospital, Anesthesiology Department, Hacisaban Mahallesi, Yeni Meram Cd. No:97, 42090 Meram/Konya
Country 82344 0
Turkey
Phone 82344 0
+90 3322210000
Fax 82344 0
Email 82344 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.